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Proposed Standard for Inactivation of Enveloped Viruses Being Developed by ASTM Pharmaceutical Committee

ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds.

“Having a set of standard steps that have been shown through multiple years of use within the industry to substantially reduce the risk related to retrovirus and using those steps during the purification process allows one to feel more confident in the use of developing drugs in clinical trials,” says Robert Steininger, chairman, E55.04.

Once it has been approved, ASTM WK39883 will benefit the producers of biological drug substances and their patients by providing parameters that assure consistent enveloped virus inactivation.

John Schreffler, senior scientist, biochemistry development, Morphotek, and an E55 member who is leading the task group on ASTM WK39883, says that an additional benefit of the proposed standard is a reduction in the cost of viral clearance and inactivation testing for biopharmaceutical drugs in early phase development. “This can allow biopharmaceutical companies to focus their spending and efforts on needed areas of development or even help to reduce the overall cost of bringing a biological drug to the commercial market,” says Schreffler.

All interested parties, particularly those involved with biologics, blood fractionation products and vaccines, are encouraged to participate in the development of ASTM WK39883.

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